Richard Wolf ESDP Model 8781.xxx Instruction Manual

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Important general instructions for use Ensure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified personnel, and that maintenance and repair is only carried out by authorized specialized technicians. Use this product only with the combinations and with the accessories and spare parts listed in the instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for this use and if the performance and safety requirements are met. Reprocess the products before every application and before returning them for repair as required by the instruction manual in order to protect the patient, user or third parties. Subject to technical changes! Due to continuous development of our products, illustrations and technical data may deviate slightly from the data in this manual.

CAUTION -- USA only: Federal law restricts this device to sale by or on the order of a physician. Symbol Level of danger (Safety instructions and levels of danger)

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WARNING!

Failure to observe can result in death or serious injury.

CAUTION!

Failure to observe can result in slight injury or damage to the product.

IMPORTANT!

Failure to observe can result in damage to the product or surrounding.

NOTE!

Tips for optimum use and other useful information.

Intended Use The ESDP Instrument Set is used for minimally invasive treatment of subfascial veins in the lower extremities. The sickle--shaped scalpel is used for cold fasciotomy. The laser guide serves to guide flexible light cables in fasciotomy.

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Indicationen and field of application

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Contraindications

For diagnosis and therapy in connection with endoscopic accessories in surgery. Contraindications directly related to the product are presently unknown.On the basis of the general condition of the patient the physician/ surgeon in charge must decide whether the planned use is possible or not. For further information see the latest medical literature.

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Combinations This instrument set is used in connection with light projectors and flexible light cables, video cameras and objective lenses, HF surgical devices, lasers, irrigators, as well as endoscopic accessories (e.g. forceps, sickle--shaped scalpel, laser guide probe, electrodes etc.)

CAUTION! When the different products are used together it is necessary that they are compatible in their intended use and relevant technical data, such as working length, diameter, electric strength etc.) Observe the instruction manuals of the products used in combination with this product.

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Caption and identification PANOVIEW Plus Operating Endoscope, 10° viewing direction, with

operating tube without olive, operating tube with olive

fig. 1,5 1, 7 1, 7 1, 7 1 1 1, 8 1 1 1 1 1,7 1 1 1 1,5 5 1 2

Item

Item 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

Designation Sheath Irrigation nozzle Objective window Light exit Working channel Handle Cold light connector Ring, red Eyepiece funnel Raised ring, red Ring, green Luer connector Luer locking cap Insufflation stopcock Indication of viewing direction Locking ring Locking grooves Operating tube without olive Operating tube with olive

fig. 3 4 4 4 4 4 4 4 4 5 6 6 6 6 7 8 8 1,2,3,4

20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 #

fig. 1 fig. 2

Designation Sickle--shaped scalpel Laser guide probe Distal guide of laser fiber Distal opening of aspiration channel Sheath Luer connector Luer locking cap Grip Rubber cap, red Guide pin of tube Guide pin of endoscope Valve insert Membrane valve Sealing lid Sealing cap Double bulb Video camera with objective lens Flexible light cable Model/type no.

Symbol in conformity with Medical Devices Directive 93/42/EC. Only valid if the product and/or the packaging is identified with this symbol. Products as of category IIa are additionally identified with the code no. of the notified body (0124).

6 Application 6.1 Preparation Check assembly. Screw on luer locking cap (13). (Fig.1) When using the laser guide, screw on luer locking cap (Fig. 24) . (Fig.4) Attaching and locking the tube (18/19) (fig. 5). Slide locking ring (16) on tube (18/19) in proximal direction and hold. Insert sheath (1) in the tube (18/19) as far as it will go, in such a way that the guide pins of the endoscope (28) and the tube (27) are aligned, let go of locking ring (15). Pull the tube (18/19) axially to check that it is firmly in place. Perform a check. (Chapter 7 ) Connect flexible light cable (33) to cold light connector (7) (fig. 8). Connect video camera with objective lens (32) to eyepiece funnel (9). (fig. 8)

6.2 Additional instructions for use Upon preparation of the passage by way of incision, place the scope with the tube (17/18) attached.

CAUTION! The instruments have only limited strength. Excessive force can lead to damage and impair their function. NOTE! During CO Insufflation: The use of valve insert (29) and membrane valve (30) permits insertion of auxiliary instruments without gas loss. Tighten valve insert (29) and membrane valve (30) in opposite direction as indicated by the arrows in fig. 6. IMPORTANT! The distal end of the sheath (1) can be damaged if instruments (forceps, scissors) are retracted or withdrawn while still open. Insert and withdraw instruments only when closed. fig.(9) NOTE! To rotate the tube (18/19) relative to the endoscope in order to extend the operating area, slide the locking ring (16) proximally, turning it at the same time. Upon completion rotate the tube (18/19) back to its home position (fig. 5). NOTE! If the objective window (3) becomes soiled during the intervention, use a conventional syringe and saline (NaCl) solution to rinse the window via the luer connector (12). For this, unscrew luer locking cap (13) and screw it on again after cleaning. In the case of heavy soiling the scope can be removed from the tube (17/18) and cleaned during the intervention. IMPORTANT! Use only products with type BF applied parts in connection with the endoscope. For maximum light efficiency the glass fibre cross--section of the flexible light cable (34) and the endoscope must be the same. WARNING! Danger from heat due to high light energy! Insufficient distance between the light exit area (4) and the tissue can destroy the tissue. Do not touch the light exit area (4) and avoid direct contact with tissue. Fire hazard! Do not place the light exit area against heat- sensitive flammable surfaces, (such as dark drapes etc.), as this can lead to excessive heating or ignition of the surface. Switch off the light source if you are not using the endoscope for sometime.

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CAUTION! If lasers are used: Danger of eye injuries! If a lasers is used, also use a suitable plug - on filter on the eyepiece of the scope and wear adequate personal protection gear. CAUTION! If a laser is used there is the danger of inadvertent tissue damage, as well as damage to the distal end of the endoscope and parts of the instrument. Activate the laser only after the tip of the laser fiber has become visible through the scope and has been directed towards the tissue to be treated. Observe the laser device manufacturer’s instructions and the general regulations on the use of laser devices. WARNING! Leakage currents! Patient leakage currents can add up if electrically powered endoscopic accessories or other electrically operated products are connected to the endoscope. Danger of electrical shock! Measure / test the combination. WARNING! Activate HF instruments only after they have become visible through the scope and if tissue contact is ensured. CAUTION! If high - frequency (HF) current is used: During activation, live HF conducting parts of high - frequency (HF) instruments must be at a distance of at least 10 mm from the distal end of the sheath (1), (fig. 10). Observe the notes and instructions on HF application (GA - S 002) and the HF device manufacturer’s instructions.

6.3 Disassembly Disconnect flexible light cable (34). Disconnect the video camera and objective lens (35) in reverse order as shown in fig. 8. Removing the tube (18/19). (fig. 5) Slide the locking ring (16) on the tube (18/19) proximally and hold. Take the endoscope out of the tube (18/19) in reverse order as shown in fig. 5. Screw on the luer locking cap (13) in opposite direction as shown in fig. 1. Unscrew the luer locking cap (24) from the laser guide in opposite direction as shown in fig. 4. Open the insufflation stopcock (14). Unscrew sealing lid (31) and remove sealing cap (32). (fig. 6) Remove valve insert (29). (fig. 6) Remove membrane valve (30) and discard. (fig. 6) IMPORTANT! Replace membrane valve (30) after each use.

6.4 Assembly Tighten sealing lid (31) and sealing cap (32) in reverse order as shown in fig. 6. CAUTION! Install membrane valve (30) only in connection with valve insert (29). (see chapter 6.2) NOTE! The cold light connector (7) can be unscrewed and replaced with suitable adapters for the connection of flexible light cables (34) of other manufacturers. (fig. 7)

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Checks Check instruments and accessories for damage, sharp edges and rough surfaces. Replace brittle or cracked sealing caps (32). The tube (18/19) must be firmly locked in place. The labeling must be complete and legible. NOTE! Do not use instruments once they have become damaged. Return damaged instruments to the factory for repair.

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Reprocessing and maintenance Disassembly before cleaning. (chapter 6.3) Clean irrigation channel and irrigation nozzle (2). (fig. 7) Hold a conventional syringe, e.g. 100 ml, or a water jet cleaning gun against the luer connector (12) and rinse the irrigation channel and irrigation nozzle (2). Dry any residual liquid in the irrigation channel and nozzle (2) via luer connector (12) using the double bulb (33). Rinse the endoscopes first with cold and then with warm water. Clean the light entry and light exit surfaces as well as the glass surfaces with a cotton swab. (fig. 11) Clean the working channel (5) with a cleaning brush. Follow the ”General instructions on the reprocessing of rigid R. Wolf endoscopes and accessories”, order no.: GA--J 020, where the following procedures are described in detail. Manual Reprocessing Machine Reprocessing Decontamination by immersion Dry preparation for reprocessing NOTE! To avoid deposits and clogging, blow dry the irrigation channel and irrigation nozzle (2) with the double bulb (33) immediately after decontamination (fig. 7).

Manual cleaning / disinfection

Machine cleaning / disinfection

Assembly before sterilisation Checking (chapter 7) Steam sterilization

at 134°C (272°F) using the fractional method.

NOTE! Recommended storage container for sterilization: Richard Wolf RIWO SYSTEM TRAY 38201.386

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Operating, storage, transport and shipping conditions Operating conditions

+ 10°C to + 40°C , 30% to 75% rel. humidity , atmospheric pressure 700 hPa to 1060 hPa

Storage, transport and shipping conditions

-- 20°C to + 60°C , 10% to 90% rel. humidity , atmospheric pressure 700 hPa to 1060 hPa

NOTE! To prevent damage when you transport or ship the products we recommend using the original packaging material.

10 Disposal of the product, packaging material and accessories For the disposal observe the relevant regulations and laws valid in your country. For further information please contact the manufacturer.

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Technical data and order data

11.1 Spare parts Item Fig. Designation SEALING CAP CAP 32 6 3.4--5.1MM, blue 31 6 Sealing cap CLEANING BRUSH Ø 12MM TL 700MM 26 4 RUBBER CAP CAP 0.5MM

Type no.

Item Fig. Designation

89.02

Type no.

LUER LOCK CONNECTOR

886.00

15176.097

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Luer locking cap

887.00

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33

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DOUBLE BELLOWS

127.00

88.005

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ADAPTER ENDOSCOPE SIDE

8095.00

11.2 Accessories Item fig.

Designation Type no. Item fig. Designation Type no. SICKLE KNIFE Ø 4.8MM 8781.901 27 6 VALVE INSERT 8781.981 WL 340MM 4 Laser guide 8781.251 28 6 Valve membrane, pack of 10 8920.911 4 24 Luer locking cap Additional recommended accessories: 3.5 mm dia --5.5 dia mm forceps, dissectors, bipolar forceps and clip applicators with a minimum working length of 290 mm. Light cable 3.5 mm dia -- 4.5 mm dia. C--Mount objective lenses, 27 mm or 30 mm focal length, in combination with R. Wolf video systems. The instruments can be combined as required provided their technical data and intended uses are compatible. For an overview of the total range please refer to the latest catalog sheets and brochures or contact Richard Wolf GmbH or your local R.Wolf representative.

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GERMANY RICHARD WOLF GmbH D--75438 Knittlingen Pforzheimerstr. 32 Tel.: (..49)--(0)7043--35--0 Fax: (..49)--(0)7043--35300 MANUFACTURER E--mail: [email protected] Internet: www.richard--wolf.com

USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Tel.: 847--913 1113 Fax: 847--913 14 88 E--mail: sales&[email protected] Internet: www.richardwolfusa.com

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW 17 0HB Tel.: 020--8944 7447 Fax: 020--8944 1311 E--mail: [email protected] Internet: www.richardwolf.uk.com

BELGIUM N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 B--9031 Gent --Drongen Tel.: +32 9.280.81.00 Fax: +32 9.282.92.16 E--mail: [email protected]

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F--51100 Reims Tel.: +33 3.26.87.02.89 Fax: +33 3.26.87.60.33 E--mail: [email protected]

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a A--1160 Wien Tel.: +43 1-- 405 51 51 Fax: +43 1-- 405 51 51--45 E--mail: [email protected] Internet: www.richard--wolf.at